Chylous AscitesPhase 2NCT06820320
Oral Iohexol in the Management of Chylous Ascites After After Retroperitoneal or Extended Lymphadenectomy
A Phase 2 study testing oral iohexol and Lymphangiography and Embolization in people with Chylous Ascites and Abdominal Neoplasm, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The goal of this clinical trial is to assess the effectiveness of oral iohexol in the treatment of postoperative chylous ascites. It will also learn about the safety of oral iohexol. The main questions it aims to answer are: Confirm the potential of oral iohexol as an innovative therapeutic regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chylous Ascites, Abdominal Neoplasm, Pelvic Neoplasms
- What is being tested?
- oral iohexol and Lymphangiography and Embolization
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2025to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18 and 75 years;
- Patients underwent retroperitoneal or extended lymphadenectomy for abdominal or pelvic malignant tumors;
- Patients diagnosisted with postoperative Chylous ascites. Chylous ascites were defined by the presence of non-infectious, milky, or creamy effluent in drainage tubes surpassing 200 mL daily, paired with triglyceride concentrations exceeding 110 mg/dL
Who cannot join
- Patients with severe cardiac, hepatic and renal insufficiency;
- Patients with a history of iohexol allergy or allergy to contrast media;
- Patients who have received other interventions;
- Patients with severe intestinal obstruction or intestinal perforation;
- Patients who are unable to comply with the requirements of the study or are unable to complete follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: Oral Iohexol in the Management of Chylous Ascites After Retroperitoneal or Extended Lymphadenectomy for Abdominal or Pelvic Malignant Tumor: An Innovative and Convenient Treatment
The goal of this clinical trial is to assess the effectiveness of oral iohexol in the treatment of postoperative chylous ascites. It will also learn about the safety of oral iohexol. The main questions it aims to answer are:
- Confirm the potential of oral iohexol as an innovative therapeutic regimen.
- Confirm its ability to improve clinical outcomes for patients.
- Conditions
- Chylous Ascites, Abdominal Neoplasm, Pelvic Neoplasms, Retroperitoneal Lymph Node Metastasis, Retroperitoneal Lymphadenectomy, Extended Lymphadenectomy
- Being tested
- oral iohexol, Lymphangiography and Embolization
- Keywords
- Oral Iohexol, Chylous Ascites, Retroperitoneal Lymphadenectomy, Extended Lymphadenectomy, Abdominal Malignant Tumor, Pelvic Malignant Tumor
- Medical subject headings
- Chylous Ascites, Abdominal Neoplasms, Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral iohexolDrug
Upon diagnosing chylous ascites, patients received oral iohexol treatment, a critical intervention in our therapeutic armamentarium. The initial oral dose was standardized to ensure a balance between efficacy and patient safety. In the event of a less than optimal response or significant drainage within the first 24 hours, a second identical dose of Iohexol was considered to maintain therapeutic concentration levels in the body.
Lymphangiography and EmbolizationProcedure or surgery
When conservative methods fall short in resolving chylous ascites, our protocol advances to precise interventional treatments. The escalation begins with ultrasound-guided lymphangiography. Through unilateral or bilateral inguinal lymph node access, iodized oil contrast is infused via a 9 ml/hour micro-pump, meticulously monitored by fluoroscopic imaging at 3-5 minutes intervals.
Following precise localization of the leakage site, embolization is performed with a sequence of carefully calibrated steps. The process entails cone-beam CT scanning and 3D reconstruction for a clear depiction of the leak, followed by direct needle access to the lymphatic rupture under DSA guidance. A fine guidewire is inserted above the rupture, which facilitates the delivery of an embolizing mixture of iodized oil and NBCA glue. This is done with the utmost precision to prevent any spillage, ensuring the embolization's success and marking the conclusion of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| oral iohexol group | Experimental | Not described Receives: Drug: oral iohexol; Procedure: Lymphangiography and Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
grading system for efficacy of iohexol intervention
The clinical responses post-Iohexol administration were evaluated against a set grading system:Grade A Success: This grade was assigned to patients who achieved complete cessation of lymphatic drainage with no clinical evidence of chylous ascites by the end of the first week post-treatment. To further ascertain the rapid action of Iohexol, 'Grade A+ Success' was defined for scenarios where this resolution occurred within the initial 3 days post-intervention. Grade B Success: Representing a substantial but partial therapeutic response, Grade B was denoted for patients who exhibited more than a 50% reduction in baseline lymphatic drainage within the first week, but did not meet the criteria for Grade A success. Non-responders: Patients who did not conform to the criteria for Grade A or B success were categorized as non-responders. This group was identified for further evaluation and considered for additional treatment modalities.
Measured: up to 3 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start15 Feb 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chylous AscitesStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820320
- Sponsor's protocol ID
- No, 24/368-4648
- Status last verified
- Dec 2025
- First submitted
- 16 Jan 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grist TM, Canon CL, Fishman EK, Kohi MP, Mossa-Basha M. Short-, Mid-, and Long-term Strategies to Manage the Shortage of Iohexol. Radiology. 2022 Aug;304(2):289-293. doi: 10.1148/radiol.221183. Epub 2022 May 19.
PubMed 35587228
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Iohexol in the Management of Chylous Ascites After Retroperitoneal or Extended Lymphadenectomy for Abdominal or Pelvic Malignant Tumor: An Innovative and Convenient Treatment
- ClinicalTrials.gov ID
- NCT06820320
- Acronym / sponsor ID
- No, 24/368-4648
- Conditions
- Chylous Ascites, Abdominal Neoplasm, Pelvic Neoplasms, Retroperitoneal Lymph Node Metastasis, Retroperitoneal Lymphadenectomy, Extended Lymphadenectomy
- Keywords
- Oral Iohexol, Chylous Ascites, Retroperitoneal Lymphadenectomy, Extended Lymphadenectomy, Abdominal Malignant Tumor, Pelvic Malignant Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess the effectiveness of oral iohexol in the treatment of postoperative chylous ascites. It will also learn about the safety of oral iohexol. The main questions it aims to answer are:
- Confirm the potential of oral iohexol as an innovative therapeutic regimen.
- Confirm its ability to improve clinical outcomes for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oral iohexol group | Experimental | Drug: oral iohexol, Procedure: Lymphangiography and Embolization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between the ages of 18 and 75 years;
- Patients underwent retroperitoneal or extended lymphadenectomy for abdominal or pelvic malignant tumors;
- Patients diagnosisted with postoperative Chylous ascites. Chylous ascites were defined by the presence of non-infectious, milky, or creamy effluent in drainage tubes surpassing 200 mL daily, paired with triglyceride concentrations exceeding 110 mg/dL
Key exclusion criteria (5 listed)
- Patients with severe cardiac, hepatic and renal insufficiency;
- Patients with a history of iohexol allergy or allergy to contrast media;
- Patients who have received other interventions;
- Patients with severe intestinal obstruction or intestinal perforation;
- Patients who are unable to comply with the requirements of the study or are unable to complete follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral iohexolUpon diagnosing chylous ascites, patients received oral iohexol treatment, a critical intervention in our therapeutic armamentarium. The initial oral dose was standardized to ensure a balance between efficacy and patient safety. In the event of a less than optimal response or significant drainage within the first 24 hours, a second identical dose of Iohexol was considered to maintain therapeutic concentration levels in the body. | Drug | oral iohexol group |
| Lymphangiography and EmbolizationWhen conservative methods fall short in resolving chylous ascites, our protocol advances to precise interventional treatments. The escalation begins with ultrasound-guided lymphangiography. Through unilateral or bilateral inguinal lymph node access, iodized oil contrast is infused via a 9 ml/hour micro-pump, meticulously monitored by fluoroscopic imaging at 3-5 minutes intervals. Following precise localization of the leakage site, embolization is performed with a sequence of carefully calibrated steps. The process entails cone-beam CT scanning and 3D reconstruction for a clear depiction of the leak, followed by direct needle access to the lymphatic rupture under DSA guidance. A fine guidewire is inserted above the rupture, which facilitates the delivery of an embolizing mixture of iodized oil and NBCA glue. This is done with the utmost precision to prevent any spillage, ensuring the embolization's success and marking the conclusion of the procedure. | Procedure or surgery | oral iohexol group |
Primary outcome
grading system for efficacy of iohexol intervention
Time frame: up to 3 weeks after the intervention
The clinical responses post-Iohexol administration were evaluated against a set grading system:Grade A Success: This grade was assigned to patients who achieved complete cessation of lymphatic drainage with no clinical evidence of chylous ascites by the end of the first week post-treatment. To further ascertain the rapid action of Iohexol, 'Grade A+ Success' was defined for scenarios where this resolution occurred within the initial 3 days post-intervention. Grade B Success: Representing a substantial but partial therapeutic response, Grade B was denoted for patients who exhibited more than a 50% reduction in baseline lymphatic drainage within the first week, but did not meet the criteria for Grade A success. Non-responders: Patients who did not conform to the criteria for Grade A or B success were categorized as non-responders. This group was identified for further evaluation and considered for additional treatment modalities.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 35587228Grist TM, Canon CL, Fishman EK, Kohi MP, Mossa-Basha M. Short-, Mid-, and Long-term Strategies to Manage the Shortage of Iohexol. Radiology. 2022 Aug;304(2):289-293. doi: 10.1148/radiol.221183. Epub 2022 May 19.
- Individual participant dataSharing planned: No
Related trials for Chylous Ascites
RecruitingObservational study
A Prospective Natural History Study of Lymphatic Anomalies
Lymphatic Diseases, Lymphatic Abnormalities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oral iohexol and Lymphangiography and Embolization in people with Chylous Ascites and Abdominal Neoplasm, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
grading system for efficacy of iohexol intervention (time frame: up to 3 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06820320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.